A multicenter evaluation of a point of care CRP Test

Volkher Scharnhorst (Corresponding author), Peter G. Noordzij, Andrea Lutz, Uwe Graser, Daniel Püntener, Aitor Alquézar-Arbé

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Background: Point-of-care (POC) C-reactive protein (CRP) testing in the primary healthcare setting is a cost-effective approach for reducing antibiotic prescriptions, but has yet to be widely adopted. Methods: Analytical performance of the cobas CRP Test on the cobas b 101 system was evaluated at three POC sites and one reference laboratory. Within-run (repeatability), within-laboratory (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Method comparison (reference test: CRPNX reagent [cobas c 501 module]) and matrix/lot-to-lot comparison experiments were conducted using prospectively collected blood samples from 217 adults (apparently healthy or with clinically relevant conditions). Usability and reliability were assessed by questionnaire and error reporting. Results: Coefficients of variation (CV) for repeatability and intermediate precision ranged from 1.7%–4.0% and 1.9%–4.5%, respectively, for human serum pools containing CRP 4.7–350.7 mg/L; repeatability in clinical samples ranged from 1.6%–5.9% (3.3–360.3 mg/L). CVs for reproducibility ranged from 2.5%–4.0% (4.7–344.3 mg/L). CRP concentrations were comparable for capillary whole blood, serum, Li-heparin whole blood/plasma, K2 and K3 EDTA whole blood/plasma (Pearson's r ≥ 0.996), and among three CRP Test lots (r ≥ 0.993). Clinically relevant CRP concentrations measured with the CRP Test showed good agreement with those measured by CRPNX reagent (serum, weighted Deming regression y = 0.97× + 0.11; Pearson's r ≥ 0.996). The overall mean usability score was 4.18/5 and the error rate across 9378 tests was 1.00%. Conclusions: The cobas CRP Test on the cobas b 101 system demonstrates robust analytic performance when used by healthcare professionals in the POC setting.

LanguageEnglish
Pages38-45
JournalClinical Biochemistry
Volume71
Issue numberSept 2019
DOIs
StatePublished - 1 Sep 2019

Fingerprint

Point-of-Care Systems
C-Reactive Protein
Blood
Serum
Plasmas
Edetic Acid
Prescriptions
Heparin
Primary Health Care
Anti-Bacterial Agents
Delivery of Health Care
Costs and Cost Analysis

Keywords

  • Antibiotic use
  • C-reactive protein
  • Diagnostic equipment
  • Infection
  • Inflammation
  • Laboratory medicine
  • POC CRP Test
  • Point-of-care testing

Cite this

Scharnhorst, V., Noordzij, P. G., Lutz, A., Graser, U., Püntener, D., & Alquézar-Arbé, A. (2019). A multicenter evaluation of a point of care CRP Test. Clinical Biochemistry, 71(Sept 2019), 38-45. DOI: 10.1016/j.clinbiochem.2019.06.009
Scharnhorst, Volkher ; Noordzij, Peter G. ; Lutz, Andrea ; Graser, Uwe ; Püntener, Daniel ; Alquézar-Arbé, Aitor. / A multicenter evaluation of a point of care CRP Test. In: Clinical Biochemistry. 2019 ; Vol. 71, No. Sept 2019. pp. 38-45
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abstract = "Background: Point-of-care (POC) C-reactive protein (CRP) testing in the primary healthcare setting is a cost-effective approach for reducing antibiotic prescriptions, but has yet to be widely adopted. Methods: Analytical performance of the cobas CRP Test on the cobas b 101 system was evaluated at three POC sites and one reference laboratory. Within-run (repeatability), within-laboratory (intermediate precision), and between-laboratory precision (reproducibility) were assessed. Method comparison (reference test: CRPNX reagent [cobas c 501 module]) and matrix/lot-to-lot comparison experiments were conducted using prospectively collected blood samples from 217 adults (apparently healthy or with clinically relevant conditions). Usability and reliability were assessed by questionnaire and error reporting. Results: Coefficients of variation (CV) for repeatability and intermediate precision ranged from 1.7{\%}–4.0{\%} and 1.9{\%}–4.5{\%}, respectively, for human serum pools containing CRP 4.7–350.7 mg/L; repeatability in clinical samples ranged from 1.6{\%}–5.9{\%} (3.3–360.3 mg/L). CVs for reproducibility ranged from 2.5{\%}–4.0{\%} (4.7–344.3 mg/L). CRP concentrations were comparable for capillary whole blood, serum, Li-heparin whole blood/plasma, K2 and K3 EDTA whole blood/plasma (Pearson's r ≥ 0.996), and among three CRP Test lots (r ≥ 0.993). Clinically relevant CRP concentrations measured with the CRP Test showed good agreement with those measured by CRPNX reagent (serum, weighted Deming regression y = 0.97× + 0.11; Pearson's r ≥ 0.996). The overall mean usability score was 4.18/5 and the error rate across 9378 tests was 1.00{\%}. Conclusions: The cobas CRP Test on the cobas b 101 system demonstrates robust analytic performance when used by healthcare professionals in the POC setting.",
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Scharnhorst, V, Noordzij, PG, Lutz, A, Graser, U, Püntener, D & Alquézar-Arbé, A 2019, 'A multicenter evaluation of a point of care CRP Test' Clinical Biochemistry, vol. 71, no. Sept 2019, pp. 38-45. DOI: 10.1016/j.clinbiochem.2019.06.009

A multicenter evaluation of a point of care CRP Test. / Scharnhorst, Volkher (Corresponding author); Noordzij, Peter G.; Lutz, Andrea; Graser, Uwe; Püntener, Daniel; Alquézar-Arbé, Aitor.

In: Clinical Biochemistry, Vol. 71, No. Sept 2019, 01.09.2019, p. 38-45.

Research output: Contribution to journalArticleAcademicpeer-review

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Scharnhorst V, Noordzij PG, Lutz A, Graser U, Püntener D, Alquézar-Arbé A. A multicenter evaluation of a point of care CRP Test. Clinical Biochemistry. 2019 Sep 1;71(Sept 2019):38-45. Available from, DOI: 10.1016/j.clinbiochem.2019.06.009